BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 3983501 · Received August 6, 2014

    Report

    Report Number
    2937094-2014-00686
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Date of Event
    June 17, 2014
    Report Date
    July 14, 2014
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)
    Product Code
    GEX
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION: (B)(4). THE FIBER SHOWS A CIRCUMFERENTIAL FRACTURE DISTAL TO FIBER/CAP FUSION ZONE AT THE BEVEL EDGE; THE FIBER PROXIMAL TO FRACTURE CAN ROTATE INDEPENDENTLY OF METAL CAP; THE GLASS CAP EXHIBITS MODERATE DEVITRIFICATION AT THE OUTPUT WINDOW; THE METAL CAP EXHIBITS MILD CHAR; THE PROXIMAL PART OF THE INLET FLOW TUBING IS CUT AND NOT RETURNED. BASED ON THE ANALYSIS ABOVE, THE POTENTIAL FOR FORWARD FIRING MAY EXIST. PROBABLE ROOT CAUSE: BASED ON THE PRODUCT ANALYSIS RESULTS, THE PROBABLE ROOT CAUSE OF THE FAILURE IS: HEAT ACCUMULATION. CAP WEAR WAS ACCELERATED DUE TO ANATOMICAL/PROCEDURAL FACTORS (TISSUE CONTACT AND TECHNIQUE) ENCOUNTERED DURING THE PROCEDURE WHICH WOULD LIMIT THE PERFORMANCE OF THE FIBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT 145,143 JOULES WHILE USING THE SIDE-FIRING SURGICAL FIBER DURING A PROSTATE PROCEDURE, THE OUTPUT BEAM WAS OBSERVED TO BE END-FIRING (FORWARD-FIRING). THE PROCEDURE WAS COMPLETED USING A SECOND SURGICAL FIBER. NO PATIENT INJURY WAS REPORTED. GLAND VOLUME: 150 CC, TIME EXPENDED: 31.52 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460182 GREENLIGHT MOXY FIBER OPTIC POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE) 0010-2400 408A

    Patients

    Seq Age Sex Outcome Treatment
    1